Metered Access

Crain's Detroit Business is a metered site. Print and digital subscribers have unlimited access to stories, but registered users are limited to eight stories every 30 days. After viewing three metered stories, you'll be asked to register or log in. After eight more stories in 30 days, you'll be asked to subscribe.

Surprise results give birth to CytoPherx

The $34 million investment in Ann Arbor-based CytoPherx Inc. in January was unusually large for a company in Southeast Michigan, but not as unusual as the company's path to market thus far.

In an era of computer modeling, high-speed analytical tools, finely tuned business plans and cadres of consultants, CytoPherx's success shows there is still plenty of room in science for just plain luck.

What attracted its newest East and West Coast investors were dramatic results from a pilot study completed last March, followed by approval by the U.S. Food and Drug Administration to begin a much larger study.

In the first study, 35 patients in six U.S. hospitals, all suffering from life-threatening kidney injuries from such things as gunshots, car accidents, cardiac arrest and fungal infection, were treated with CytoPherx's blood-filtering device.

Generally, after two months, the death rate for such patients is about 50 percent. Of those in the CytoPherx study, though, mortality fell to 31.4 percent. And none of the survivors needed kidney dialysis after 60 days, compared to the expected range of 6 percent to 20 percent.

About 160,000 U.S. patients annually suffer acute kidney failure from injury or infection. About 80,000 of them are now expected to die. If CytoPherx can reduce mortality to 35 percent, that would mean a savings of 24,000 lives a year.

The latest venture capital round will now fund a much larger study, which began recruiting patients in September. It will test 344 patients in up to 30 sites and is expected to last 12 to 15 months.

"This funding will take us through our larger patient trial and through the FDA approval process," said CEO Jim Danehy. He said that if testing goes according to plan, the company could have a device on the market by the end of 2013.

All of which is a result of pure serendipity and an unexpected result in a previous failed study, which led a University of Michigan professor named H. David Hume to cast one intended business aside for another.

In 2006, CytoPherx's predecessor, a North Coast-backed company called Nephrion Inc., was involved in human trials of a medical device invented by Hume that incorporated stem cells on its inside.

As part of the trial, one group of patients was treated with what was meant to be a placebo, a sham device meant to do nothing. It was basically a tube containing a dialysis filter, with a patient's blood running through the tube but on the outside of the filter instead of the inside, which is how the blood would flow during dialysis.

To Hume's surprise, the cell-based device didn't do as well as expected. To his greater surprise, patients on the sham filter showed significant improvement.

It turned out that citrate, which was used to prevent blood clotting in the kidney patients, helped precipitate white blood cells out of patients' blood and onto the outside surface of the dialysis filter -- reducing the mortality rate dramatically.

White blood cells can cause an immune response in patients with severe kidney injuries, actually killing them before they die of kidney failure.

A new business, CytoPherx, a combination of the prefix "cyto," meaning cell, and "pheresis," meaning migration, was the result. Eight patents are pending.

Company CFO Mark Morsfield said that if approval is given to treat kidney patients, the company will then explore using the technology to treat a broad range of organ failures due to immune responses, including liver, lung and heart failure.

"This is really an incredible opportunity," said Leslie Bottorff, managing director at Menlo Park, Calif.-based Onset Ventures, which led the $34 million investment in January.

"There's been nothing new in the last 20 or 30 years that has moved the needle on mortality rates for kidney injuries. If the company can replicate the data from the pilot trial, this can be a game changer."